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ClinicalTrials.gov Identifier: NCT00975611

Recruitment Status :
Terminated
(The sponsor withdrew support due to slow accrual of eligible subjects.)

Subjects were recruited from the Freedom Trail Clinic, MGH Schizophrenia Program

Pre-assignment Details

Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria, and 1 screen failed due to a positive drug screen.

Arm/Group Title

All Consented Subjects

Arm/Group Description

Of the 22 consented subjects, 15 sc...

Arm/Group Description

Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria, and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized (N=6), or completed (N=5), to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all consented/screened subjects (N=22) were published and are reported here.

Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized or completed to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all 22 consented/screened subjects were published and are reported here.

Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Only baseline characteristics of all 22 consented/screened subjects were published and are reported here.

Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized or completed to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all 22 consented/screened subjects were published and are reported here.

All-Cause Mortality

All Consented Subjects

Affected / at Risk (%)

Total

--/--

Serious Adverse Events Serious Adverse Events

All Consented Subjects

Affected / at Risk (%)

Total

0/6 (0.00%)

Other (Not Including Serious) Adverse Events Other (Not Including Serious) Adverse Events

Too few subjects met study's eligibility criteria to run statistical analyses on primary outcomes. The baseline demographic data are reported here. Future research is needed to understand the prevalence of elevated prolactin in schizophrenia.